PerspectiveDiagnostics

COVID-19 diagnostics in context

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Science Translational Medicine  03 Jun 2020:
Vol. 12, Issue 546, eabc1931
DOI: 10.1126/scitranslmed.abc1931
  • Table 1 Performance comparison of different test types.

    Throughput is determined by process type and assay time. In general, automated plate-based assays have higher daily throughputs. Hashtag (#) indicates example systems that have received FDA emergency use authorization (FDA-EUA). See https://csb.mgh.harvard.edu/covid to access continuously updated information. PCR, polymerase chain reaction; PCR-POC, PCR–point-of-care; ddPCR, digital droplet PCR; NEAR, nicking endonuclease amplification reaction; RCA, rolling circle amplification; SHERLOCK, specific high-sensitivity enzymatic reporter; DETECTR, DNA endonuclease-targeted CRISPR transreporter; NGS, next-generation sequencing; μNMR, micro–nuclear magnetic resonance; LFA, lateral flow assay; ELISA, enzyme-linked immunosorbent assay; CLIA, chemiluminescence immunoassay; EIA, enzyme immunoassay; ECLIA, electrochemiluminescence immunoassay; ECS, electrochemical sensing; VAT, viral antigen assay; IFM, immunofluorescence microscopy; WB, Western blot.

    TypeTargetVirusAssay timeProcess typeFDA-EUAExamples
    PCRViral RNASARS-CoV-22–8 hours; >12 hoursPlate56#Roche, #LabCorp,
    #BioMerieux,
    #Qiagen,
    #Perkin-Elmer,
    #Becton Dickinson,
    #Luminex, #Thermo
    Fisher, others
    PCR-POCViral RNASARS-CoV-2<1 hourCartridge2#Cepheid, #Mesa,
    Credo
    ddPCRViral RNASARS-CoV-22–4 hoursManual1#BioRAD
    NEARViral RNASARS-CoV-215 minCartridge1#Abbott
    OMEGAViral RNASARS-CoV-21 hourPlate1#Atila BioSystems
    RCAViral RNASARS-CoV2 hours0
    SHERLOCKViral RNASARS-CoV-21.5 hoursKit1#Sherlock
    Biosciences
    (CAS13a)
    DETECTRViral RNASARS-CoV-21 hourKit0Mammoth
    Biosciences
    (CAS12a)
    NGSViral RNASARS-CoV-2Days1#IDbyDNA, Vision,
    Illumina
    μNMRViral RNASARS-CoV-22 hoursCartridge0T2 Biosystems
    LFAIgG, IgMSARS-CoV-215 minCartridge3#Cellex,
    #Sugentech,
    #ChemBio, Innovita
    ELISAIgG, IgMSARS-CoV-22–4 hoursPlate4#Mount Sinai,
    #Ortho-Clinical (2),
    #EUROIMMUN US
    Inc., BioRAD, Snibe,
    Zhejiang orient,
    Creative Dx
    CLIAIgG, IgMSARS-CoV-230 minCartridge2#Abbott, #DiaSorin
    EIAIgG, IgMSARS-CoV-22 hoursPlate1#BioRAD
    MIAIgG, IgMSARS-CoV-2Plate1#Wadsworth Center
    ECLIAIgG, IgMSARS-CoV-220 minPlate1#Roche
    ECSIgG, cytokineSARS-CoV-21 hourCartridge0Accure Health
    VATViral antigenSARS-CoV-220 minCartridge1#Quidel, Sona NT,
    RayBiotech, SD
    Biosensors, Bioeasy
    MicroarraysIg epitopesSARS-CoV-21.5 hoursPlate0RayBiotech,
    PEPperPRINT
    IFMViral proteinSARS-CoV3 hoursManual0
    WBIgG, IgM; viral proteinSARS-CoV4 hoursManual0
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